Insight Announces Completion of a Formal Design Control Process That Supports the FDA’s Quality System Regulation (QSR) & ISO 13485
June 9, 2006 – Insight Product Development, a world-class developer of award-winning medical devices and products, announced today that it has formally completed design control procedures for compliance with the FDA’s Quality System Regulation (QSR) and ISO 13485:2003 requirements for medical devices.
This design control process ensures that control is maintained from the planning and design stages through to implementation, verification, and ultimately design transfer to manufacturing.
"This is about added reassurance for our clients," commented Craig Scherer, founding partner, Insight Product Development. "With this process in place, our clients can rest assured that their medical products are being developed and documented in accordance to methodologies as mandated by the FDA."
The formal design control process was developed in conjunction with Medical Device Consultants, Inc., a leading contract research organization (CRO) and regulatory consulting practice focused on the needs of emerging and established medical device and diagnostic manufacturers in the US and internationally.
"Having the process that complies with national and international Quality System requirements such as FDA QSR and ISO 13485:2003 is critical because it facilitates efficient, quality-driven product development," said Judith Andrews, Medical Device Consultants, Inc.
Compliance with FDA QSR and ISO 13485 is a regulatory necessity for the design, production, installation, and servicing of most medical devices in many worldwide markets.
About Insight Product Development
Insight Product Development, founded in 1988, provides product development services to clients in the consumer, commercial, medical and military markets. With offices in Chicago, Boston and Raleigh and 90 professionals on staff, Insight offers clients five core competencies: user research, interface development, industrial design, engineering and prototyping.
Insight’s work has produced more than 70 utility patents, 100 design patents and 35 industry awards. In the past year, awards include: MDEA Gold Award, CES Best of Innovations Award, Best of NeoCon in Workplace Technologies, Outstanding Design Team from MD&DI magazine, six Good Design Awards and HFES User-Centered Product Design Award honorable mention.
For more information on Insight Product Development, visit the Insight website or contact 773.907.9500. >online link
About Medical Device Consultants, Inc.
Medical Device Consultants, Inc. is a full-service CRO and regulatory consulting practice focused on the needs of emerging and established medical device and diagnostic manufacturers. Since 1980, MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally. For more information on Medical Device Consultants, Inc. visit the MDCI website or contact 508.643.0434. >online link